# FDA 483 - Richard W. Foltin, Ph.D. - March 17, 2023

Source: https://www.globalkeysolutions.net/records/483/richard-w-foltin-phd/a68bb0b3-9b52-42e8-aa7d-9211c8761923

> FDA 483 for Richard W. Foltin, Ph.D. on March 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Richard W. Foltin, Ph.D.
- Inspection Date: 2023-03-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: This FDA Form 483 was issued to Richard W. Foltin, Ph.D., a Sponsor-Investigator in New York, NY, following an inspection from February 28 to March 17, 2023. The inspection revealed significant non-compliance with clinical investigation regulations. Observations included initiating clinical studies requiring an Investigational New Drug (IND) application before the IND was in effect, and failing to obtain required FDA-1572 investigator statements prior to investigators participating in studies.

## Related Documents

- [483 - 2019-06-21](https://www.globalkeysolutions.net/records/483/richard-w-foltin-phd/c247810a-a983-49a0-b680-b9135befa765)
- [WARNING_LETTER - 2023-03-17](https://www.globalkeysolutions.net/records/warning_letter/richard-w-foltin-phd/73bbf114-53fb-435c-b5c9-360f2ed3853d)

## Related Officers

- [Omadevi Somai](https://www.globalkeysolutions.net/people/omadevi-somai/8a6212bf-2dfa-44ea-bd2f-f2aeb78aa1bd)

Company: https://www.globalkeysolutions.net/companies/richard-w-foltin-phd/04a08162-904e-4999-9f8c-7d0b3b61bd18

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961